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A Study to Investigate Tislelizumab Administered as Subcutaneous Injection Versus Intravenous Infusion Plus Chemotherapy in Patients With Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

RecruitingPhase 3Ages 18 Years - anyAllBeOne Medicines
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In plain words

What the trial is, and whether it could suit you

This study is designed to assess the levels of drug exposure following treatment with tislelizumab administered as a subcutaneous (SC) injection compared to intravenous infusion (IV) as first-line therapy in adults with gastric or gastroesophageal junction (GEJ) that is locally advanced and cannot be surgically removed or has spread from the stomach to other areas of the body. Approximately 351 patients will be participating in this study. The study is composed of a screening period, a treatment period, and a follow-up period.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Histologically confirmed, locally advanced unresectable or metastatic gastric/ gastroesophageal junction (GEJ) adenocarcinoma. * No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. * At least 1 measurable or nonmeasurable lesion per RECIST v1.1 as determined by investigator assessment. * Must be able to provide tumor tissues for biomarker assessment. * Eastern Cooperative Oncology Group (ECOG) Performance Status score โ‰ค 1. * Adequate organ function. * Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and โ‰ฅ 120 days after the last dose of tislelizumab. * Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for โ‰ฅ 120 days after the last dose of tislelizumab. Exclusion Criteria: * Squamous cell or undifferentiated or other histological type gastric cancer (GC) * Active leptomeningeal disease or uncontrolled brain metastasis. Patients with equivocal findings or with confirmed brain metastases are eligible for enrollment provided that they are asymptomatic and radiologically stable without the need for corticosteroid treatment for โ‰ฅ 4 weeks before randomization. * Diagnosis with gastric or GEJ adenocarcinoma with positive human epidermal growth factor receptor 2 (HER2). * Active autoimmune diseases or history of autoimmune diseases that may relapse. * Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (at least once a week) and/or diuretics within 7 days prior to randomization NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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What it tests

  • Subcutaneous Tislelizumab
  • Intravenous Tislelizumab
  • Cisplatin
  • Leucovorin
  • 5-fluorouracil (5-FU)
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Where

95 sites
Ironwood Cancer and Research Centers Chandler Ii
Chandler, United States
Cancer and Blood Specialty Clinic
Los Alamitos, United States
UC Health Cancer Care and Hematology Clinic Memorial Hospital Central
Colorado Springs, United States
Bioresearch Partners Holding Hialeah Hospital
Hialeah, United States
Orlando Health Cancer Institute Downtown Orlando
Orlando, United States
Northwestern University
Chicago, United States
Hope and Healing Cancer Services
Hinsdale, United States
University of Kansas Medical Center Research Institute
Kansas City, United States

โ€ฆand 87 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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